ERGOMETER ergoselect 5 T

GUDID 04059358001630

ergoline GmbH

Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer

• Primary Device ID: 04059358001630
• NIH Device Record Key: e35eb813-f0fc-43a3-a74d-de6a0a1510d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ERGOMETER ergoselect 5 T
• Version Model Number: 191002.T
• Company DUNS: 314403192
• Company Name: ergoline GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04059358001630 [Primary]

FDA Product Code

• ISD: Exerciser, Measuring

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-11-21

Devices Manufactured by ergoline GmbH

• 04059358002224 - optibike basic: 2023-05-22
• 04059358001746 - ers2 1CH Telemetry Transmitter: 2023-05-18
• 04059358001753 - ers2 ECG Receiver: 2023-05-18
• 04059358001760 - ers2 1CH ECG Adapter: 2023-05-18
• 04059358001777 - ers2 1CH ECG Transmitter Set (Adapter): 2023-05-18
• 04059358001821 - ergoselect 1: 2023-05-18
• 04059358001838 - ers2 Basic Software: 2023-05-18
• 04059358002095 - ers2 1CH ECG Adapter US Set 5 pcs.: 2023-05-18